Periodontitis Clinical Trial
Official title:
The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis
The purpose of this study is to determine the effect of the placement of a PerioChip Plus (flurbiprofen/chlorhexidine - FBP/CHX) formulation versus PerioChip (chlorhexidine) formulation versus Flurbiprofen Chip formulation versus Placebo Chip formulation on probing pocket depth (PPD)
This is an 80 subjects, single-center, randomized, double-blinded, parallel, 4-arm clinical
study (25 subjects in the PerioChip Plus and PerioChip arms and 15 subjects in the
Flurbiprofen Chip and Placebo Chip arms).
At 24 weeks, relative to baseline, the mean reductions in probing pocket depth (PPD) will be
used as primary efficacy endpoint. Additional primary endpoints are clinical attachment
levels (CAL) and bleeding on probing (BOP) in the target pockets selected at screening,
measured at weeks 24.
PPD measurements at 6, 12 and 18 weeks will be used as secondary endpoints. Additional
secondary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in
the target pockets selected at screening, measured at weeks 6, 12 and 18.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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